Septic ShockNCT05444621
Carotid Ultrasounds Measurements in Septic Shock
An observational study of Septic Shock, run by Assiut University.
Trial summary
The aim of the study is to assess carotid ultrasounds measurements, namely corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak), as a predictor of fluid responsiveness in septic shock patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Ultrasound and doppler
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All recruited patients aged between 18 and 75 year old suspected to have septsis and septic shock are to be assessed at time of admission by history taking, thorough physical examination, laboratory workup. ECG, haemodynamic parameters and abdominal ultrasound including inferior vena cava (IVC) dimeter and collapsibility. Sequential Organ failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation (APACHE-II) score to diagnose septic shock and eligibility to enter the study .
Who may be able to join
- Adult patients (18-75 year old) diagnosed with septic shock (MAP >65mmHg), within 6 hours of admission or development of septic shock if previously admitted with other diagnoses.
Who cannot join
- patients have any of these conditions: Carotid artery stenosis ≥50%, known heart failure (Ejection fraction ≤45%) or End Stage Kidney Disease requiring haemodialysis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Carotid Ultrasounds Measurements for Assessment of Fluid Responsiveness in Septic Shock
The aim of the study is to assess carotid ultrasounds measurements, namely corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak), as a predictor of fluid responsiveness in septic shock patients.
Read the detailed description
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection . Early identification and appropriate management in the initial hours after the development of sepsis improve outcomes.
For patients with sepsis-induced hypoperfusion or septic shock it is recommended to give IV crystalloid fluid within the first 3 hr of resuscitation . However, fluid responsiveness varies widely between cases. Determining the optimal amount of fluid to be administered remains a critical issue in clinical practice and research. Recent studies have shown that not every patient advantages from intravenous hydration, only 40% of hypotensive patients with sepsis benefit, and the others who do not respond are liable to develop pulmonary edema with high associated mortality . Studies have shown that aortic blood peak velocity had high sensitivity and specificity to predict fluid responsiveness, however, measurements of aortic blood flow velocity need a transesophageal ultrasound which is an invasive procedure . Measurement of left ventricular outflow tract velocity time integral (LVOTVTI), derived stroke volume (SV), and cardiac output reliably predicts fluid responsiveness in critically ill patients but it is difficult and dependent on operator and echo windows . There is a need to find a non-invasive accurate and easy method to assess fluid responsiveness in septic shock patients. Different Measurements of carotid artery flow have been suggested recently to predict fluid responsiveness. A promising measurements are corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak).
- Conditions
- Septic Shock
- Being tested
- Ultrasound and doppler
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and dopplerRadiation
All patients are then assessed by transthoracic echocardiography to measure Left ventricle and Right ventricle function and to assess LVOT-VTI and SV. Doppler Ultrasound assessment of carotid arteries to assess corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak). The patient will be assessed pre- and post- passive leg raising (PLR) and after fluid challenge of 30 mL/Kg of IV crystalloid
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid usltrasounds and doppler measurements as predictor of fluid responsiveness in septic patient
Assess carotid artery blood flow assessed by Ultrasounds as a predictor of fluid responsiveness in septic shock patients, and compare this measurements to standard one as echocardiography measurements of stroke volume and cardiac output (COP)to establish more easier method for assessment not depend of echo-window of patient and doesn't need expert one to do.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdelhameed Mohammed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444621
- Sponsor's protocol ID
- carotid US
- Status last verified
- Jul 2022
- First submitted
- 20 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Ultrasounds Measurements for Assessment of Fluid Responsiveness in Septic Shock
- ClinicalTrials.gov ID
- NCT05444621
- Acronym / sponsor ID
- carotid US
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess carotid ultrasounds measurements, namely corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak), as a predictor of fluid responsiveness in septic shock patients.
Detailed description
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection . Early identification and appropriate management in the initial hours after the development of sepsis improve outcomes.
For patients with sepsis-induced hypoperfusion or septic shock it is recommended to give IV crystalloid fluid within the first 3 hr of resuscitation . However, fluid responsiveness varies widely between cases. Determining the optimal amount of fluid to be administered remains a critical issue in clinical practice and research. Recent studies have shown that not every patient advantages from intravenous hydration, only 40% of hypotensive patients with sepsis benefit, and the others who do not respond are liable to develop pulmonary edema with high associated mortality . Studies have shown that aortic blood peak velocity had high sensitivity and specificity to predict fluid responsiveness, however, measurements of aortic blood flow velocity need a transesophageal ultrasound which is an invasive procedure . Measurement of left ventricular outflow tract velocity time integral (LVOTVTI), derived stroke volume (SV), and cardiac output reliably predicts fluid responsiveness in critically ill patients but it is difficult and dependent on operator and echo windows . There is a need to find a non-invasive accurate and easy method to assess fluid responsiveness in septic shock patients. Different Measurements of carotid artery flow have been suggested recently to predict fluid responsiveness. A promising measurements are corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All recruited patients aged between 18 and 75 year old suspected to have septsis and septic shock are to be assessed at time of admission by history taking, thorough physical examination, laboratory workup. ECG, haemodynamic parameters and abdominal ultrasound including inferior vena cava (IVC) dimeter and collapsibility. Sequential Organ failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation (APACHE-II) score to diagnose septic shock and eligibility to enter the study .
Key inclusion criteria (1 listed)
- Adult patients (18-75 year old) diagnosed with septic shock (MAP >65mmHg), within 6 hours of admission or development of septic shock if previously admitted with other diagnoses.
Key exclusion criteria (1 listed)
- patients have any of these conditions: Carotid artery stenosis ≥50%, known heart failure (Ejection fraction ≤45%) or End Stage Kidney Disease requiring haemodialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound and dopplerAll patients are then assessed by transthoracic echocardiography to measure Left ventricle and Right ventricle function and to assess LVOT-VTI and SV. Doppler Ultrasound assessment of carotid arteries to assess corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak). The patient will be assessed pre- and post- passive leg raising (PLR) and after fluid challenge of 30 mL/Kg of IV crystalloid | Radiation | – |
Primary outcome
carotid usltrasounds and doppler measurements as predictor of fluid responsiveness in septic patient
Time frame: baseline
Assess carotid artery blood flow assessed by Ultrasounds as a predictor of fluid responsiveness in septic shock patients, and compare this measurements to standard one as echocardiography measurements of stroke volume and cardiac output (COP)to establish more easier method for assessment not depend of echo-window of patient and doesn't need expert one to do.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021.Link provided by the sponsor.
- Wu Y, Zhou S, Zhou Z, Liu B. A 10-second fluid challenge guided by transthoracic echocardiography can predict fluid responsiveness. Crit Care. 2014;;18::R108.. doi: 10.1186/cc13891. DOI:Link provided by the sponsor.
- Sidor M, Premachandra L, Hanna B, Nair N, Misra A. Carotid flow as a surrogate for cardiac output measurement in Hemodynamically stable participants. J Intensive Care Med. 2020;;35::650--655.. doi: 10.1177/0885066618775694. DOI:Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed AM Hassan (+2/01010706790, mohammedelahmer88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid usltrasounds and doppler measurements as predictor of fluid responsiveness in septic patient (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.